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Concerns persist about Byetta and pancreatitis.

The Food and Drug Administration warned physicians to immediately discontinue use of exenatide (Byetta) if pancreatitis is suspected, saying that it has received reports of six cases of necrotizing or hemorrhagic pancreatitis--including two deaths--since October 2007.

At that time, a precaution about acute pancreatitis was added to exenatide's labeling. The agency had received 30 reports of acute pancreatitis in patients taking the incretin mimetic for type 2 diabetes. Physicians were advised to discontinue exenatide injections if pancreatitis was suspected.

Now the FDA says that exenatide may also be linked to a more severe form of pancreatitis. "There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less-severe form of pancreatitis," the agency said.

In all six of the reported cases, the drug was discontinued. All patients required hospitalization; two died and four were recovering.

The FDA said it is working with exenatide maker Amylin Pharmaceuticals Inc. to "add stronger and more prominent warnings" about the risk of acute hemorrhagic and necrotizing pancreatitis to the drug's precautions section.

Exenatide should not be started in a patient with a history of pancreatitis, the FDA said. If pancreatitis is confirmed, the agency advises physicians to initiate appropriate treatment and monitor the patient until recovery. Exenatide should not be started again in that patient.

In the previous warning, 21 of the 30 patients were hospitalized; 27 had at least one other risk factor for symptoms of pancreatitis. In six patients, symptoms worsened after the dose was increased from 5 micrograms twice daily to 10 micrograms twice daily. There were no reports of acute hemorrhagic and necrotizing pancreatitis, according to the FDA.

BY ALICIA AULT Associate Editor, Practice Trends
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Title Annotation:NEWS FROM THE FDA
Author:Ault, Alicia
Publication:Internal Medicine News
Article Type:Brief article
Geographic Code:1USA
Date:Sep 15, 2008
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